Une étude de 52 semaines pour en savoir plus sur l'innocuité et les effets du ritlécitinib chez les participants atteints de vitiligo non segmentaire (Tranquillo LTE)
UNE ÉTUDE D'EXTENSION MULTICENTRE DE PHASE 3 AVEC RETRAIT ALÉATOIRE ET TITRATION DE LA DOSE, ÉTUDANT LA SÉCURITÉ, L'EFFICACITÉ ET LA TOLÉRABILITÉ DU RITLECITINIB CHEZ LES PARTICIPANTS ADULTES ET ADOLESCENTS AVEC VITILIGO NON SEGMENTAL
This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV).
Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin.
Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show:
- if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo)
- Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study
- Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study.
This study is seeking for participants who:
- have non-segmental vitiligo (either active or stable) and
- received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it.
All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. On study visit days, you must take the medication at the study site, and not at home.
Participants may receive the study medicine or placebo for up to 52 weeks.
The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo.
Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study.
Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Baden-Wurttemberg
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Stuttgart, Baden-Wurttemberg, Allemagne, 70178
- Praxis Leitz und Kollegen
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Lower Saxony
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Bad Bentheim, Lower Saxony, Allemagne, 48455
- Fachklinik Bad Bentheim
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Allemagne, 48149
- Universitätsklinikum Münster
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New South Wales
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Darlinghurst, New South Wales, Australie, 2010
- The Skin Hospital
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South Australia
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Campbelltown, South Australia, Australie, 5074
- North Eastern Health Specialists
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Victoria
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Carlton, Victoria, Australie, 3053
- Skin Health Institute Inc.
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East Melbourne, Victoria, Australie, 3002
- Dr Rodney Sinclair Pty Ltd
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Melbourne, Victoria, Australie, 3004
- The Alfred Hospital
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Stara Zagora, Bulgarie, 6003
- UMHAT "Prof. Dr. Stoyan Kirkovich"AD
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Kyustendil
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Dupnitsa, Kyustendil, Bulgarie, 2600
- Medical Centre "Asklepiy"
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Sofia (stolitsa)
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Sofia, Sofia (stolitsa), Bulgarie, 1431
- Diagnostic Consultative Center Aleksandrovska
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Québec, Canada, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Québec, Canada, G1W 4R4
- Centre de Recherche Saint-Louis inc.
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Alberta
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Calgary, Alberta, Canada, T2J 7E1
- Dermatology Research Institute
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Red Deer, Alberta, Canada, T4P 1K4
- CaRe Clinic
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Ontario
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Markham, Ontario, Canada, L3P 1X3
- Lynderm Research Inc.
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Mississauga, Ontario, Canada, L4Y 4C5
- DermEdge Research
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Toronto, Ontario, Canada, M2N3A6
- North York Research Inc
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Guangdong
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Guangzhou, Guangdong, Chine, 510091
- Dermatology Hospital of Southern Medical University
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Hubei
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Wuhan, Hubei, Chine, 430022
- The First Hospital of Wuhan
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Liaoning
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Shenyang, Liaoning, Chine, 110001
- The First Hospital of China Medical University/Dermatology and STD Department
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200040
- Huashan Hospital Fudan University
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Yunnan
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Kunming, Yunnan, Chine, 650032
- First Affiliated Hospital of Kunming Medical University
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Kyǒnggi-do
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Suwon, Kyǒnggi-do, Corée du Sud, 16247
- The Catholic University Of Korea St. Vincent's Hospital
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Suwon, Kyǒnggi-do, Corée du Sud, 16499
- Ajou University Hospital
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Seoul-teukbyeolsi [seoul]
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Seoul, Seoul-teukbyeolsi [seoul], Corée du Sud, 03722
- Severance Hospital, Yonsei University Health System
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Córdoba, Espagne, 14001
- AUDIKA
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Andalusia
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Córdoba, Andalusia, Espagne, 14004
- Hospital Universitario Reina Sofia
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Catalunya [cataluña]
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Barcelona, Catalunya [cataluña], Espagne, 08036
- Hospital Clínic de Barcelona
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LAS Palmas
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Las Palmas de Gran Canaria, LAS Palmas, Espagne, 35010
- Hospital Universitario de Gran Canaria Doctor Negrín
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Espagne, 28034
- Hospital Universitario Ramón y Cajal
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Aichi-ken
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Nagoya, Aichi-ken, Japon, 467-8602
- Nagoya City University Hospital
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Miyagi
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Sendai, Miyagi, Japon, 980-8574
- Tohoku University Hospital
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Osaka
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Sakai, Osaka, Japon, 593-8324
- Dermatology and Ophthalmology Kume Clinic
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Tokyo
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Bunkyo-ku, Tokyo, Japon, 113-8603
- Nippon Medical School Hospital
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Shinjuku-ku, Tokyo, Japon, 160-0023
- Tokyo Medical University Hospital
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Yamanashi
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Kofu, Yamanashi, Japon, 400-8506
- Yamanashi Prefectural Central Hospital
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Veracruz, Mexique, 91900
- Arké SMO S.A de C.V
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Veracruz, Mexique, 91900
- Sociedad de Metabolismo y Corazon S.C.
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Mexico City
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Mexico City, Mexico City, Mexique, 06720
- Hospital Infantil de Mexico Federico Gomez
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Nuevo León
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Monterrey, Nuevo León, Mexique, 64460
- Centro de Dermatologia de Monterrey
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Kuyavian-Pomeranian Voivodeship
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Osielsko, Kuyavian-Pomeranian Voivodeship, Pologne, 86-031
- DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Pologne, 02-962
- Royalderm Agnieszka Nawrocka
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Pologne, 71-500
- Twoja Przychodnia SCM
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Pologne, 90-436
- Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
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Świętokrzyskie Voivodeship
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Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Pologne, 27-400
- Dermedic Jacek Zdybski
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London, Royaume-Uni, SE1 9RT
- Guy's & St Thomas' NHS Foundation Trust
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Istanbul, Turquie (Türkiye), 34098
- Istanbul Universitesi Cerrahpasa
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Kayseri, Turquie (Türkiye)
- Erciyes Universitesi Tıp Fakultesi Hastaneleri
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Manisa, Turquie (Türkiye), 45030
- Celal Bayar University Hafsa Sultan Hospital
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İ̇stanbul
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Istanbul, İ̇stanbul, Turquie (Türkiye), 34899
- Marmara Universitesi Pendik Egitim Arastirma Hastanesi
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California
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Encinitas, California, États-Unis, 92024
- California Dermatology & Clinical Research Institute
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Huntington Beach, California, États-Unis, 92647
- Marvel Clinical Research
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Los Angeles, California, États-Unis, 90056
- Wallace Medical Group, Inc
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Florida
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Boynton Beach, Florida, États-Unis, 33436
- Encore Medical Research of Boynton Beach
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Hollywood, Florida, États-Unis, 33021
- Skin Care Research
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Tampa, Florida, États-Unis, 33613
- ForCare Clinical Research
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Indiana
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Indianapolis, Indiana, États-Unis, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Louisiana
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Baton Rouge, Louisiana, États-Unis, 70809
- DelRicht Research
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Maryland
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Rockville, Maryland, États-Unis, 20850
- Lawrence J. Green, MD LLC
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
- University of New Mexico Health Sciences Center
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New York
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Brooklyn, New York, États-Unis, 11203
- SUNY Downstate Health Sciences University
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27516
- University of North Carolina Medical Center
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Chapel Hill, North Carolina, États-Unis, 27599
- Clinical & Translational Research Center (CTRC)
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Wilmington, North Carolina, États-Unis, 28411
- Accellacare - Wilmington
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Wilmington, North Carolina, États-Unis, 28411
- Wilmington Health, PLLC
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Ohio
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Cleveland, Ohio, États-Unis, 44106
- University Hospitals Cleveland Medical Center
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Columbus, Ohio, États-Unis, 43215
- Remington-Davis, Inc
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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Texas
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Dallas, Texas, États-Unis, 75231
- Modern Research Associates, PLLC
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Houston, Texas, États-Unis, 77056
- Austin Institute for Clinical Research
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Houston, Texas, États-Unis, 77008
- Alpesh D. Desai, DO PLLC
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to <18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority.
- Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
- The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040
Exclusion Criteria:
- Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
- Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Arm 1
Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040. Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned. |
Ritlecitinib 50 mg capsule once daily Ritlecitinib 100 mg capsule once daily Matching capsule once daily |
|
Expérimental: Arm 2
Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned |
Ritlecitinib 50 mg capsule once daily Ritlecitinib 100 mg capsule once daily Matching capsule once daily |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
Délai: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
|
To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo |
Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
|
|
Incidence of clinically significant laboratory abnormalities
Délai: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
|
To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo |
Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52
Délai: Baseline to week 52
|
Proportion of participants achieving at least a 75% improvement in T-VASI from Baseline |
Baseline to week 52
|
|
Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52
Délai: Baseline to week 52
|
Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline |
Baseline to week 52
|
|
Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52
Délai: Baseline to Week 52
|
Proportion of participants achieving at least a 50% improvement in T-VASI from Baseline |
Baseline to Week 52
|
|
Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52
Délai: Baseline to week 52
|
Proportion of participants achieving at least a 50% improvement in F-VASI from Baseline |
Baseline to week 52
|
|
Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52
Délai: Baseline to week 52
|
Proportion of participants achieving at least a 90% improvement in T-VASI from Baseline |
Baseline to week 52
|
|
Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52
Délai: Baseline to week 52
|
Proportion of participants achieving at least a 90% improvement in F-VASI from Baseline |
Baseline to week 52
|
|
Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52
Délai: Baseline to week 52
|
Proportion of participants achieving at least a 100% improvement in T-VASI from Baseline |
Baseline to week 52
|
|
Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52
Délai: Baseline to week 52
|
Proportion of participants achieving at least a 100% improvement in F-VASI from Baseline |
Baseline to week 52
|
|
Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52
Délai: Baseline to week 52
|
To assess the effect of ritlecitinib compared to placebo on the PGIC-F at weeks 24, 36, and 52 |
Baseline to week 52
|
|
Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52
Délai: Baseline to week 52
|
To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Week 24, 36, and 52 |
Baseline to week 52
|
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Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52
Délai: Baseline to week 52
|
To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Week 24, 36, and 52 |
Baseline to week 52
|
|
Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52
Délai: Baseline to week 52
|
To assess the effect of ritlecitinib compared to placebo on the PGIC-V at weeks 24, 36, and 52 |
Baseline to week 52
|
|
Proportion of participants achieving disease stabilization
Délai: Baseline to week 52
|
The difference in the proportion of participants with stable disease at all scheduled timepoints |
Baseline to week 52
|
|
Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52
Délai: Baseline to week 52
|
To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo |
Baseline to week 52
|
|
Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52
Délai: Baseline to week 52
|
To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo |
Baseline to week 52
|
|
Time to loss of response (<F-VASI75 and <T-VASI50 at the same visit).
Délai: Baseline to week 52
|
To compare the efficacy of ritlecitinib 100 mg QD, 50 mg QD, and placebo |
Baseline to week 52
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B7981041
- 2023-505804-42-00 (Identificateur de registre: CTIS (EU))
- 2023 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informations sur les médicaments et les dispositifs, documents d'étude
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